When necessary to restrict information to protect commercially confidential information and intellectual property rights on rare occasions.

Data collected subject to legal, contractual or consent provisions that prevent further sharing of clinical data will be excluded.

Clinical studies where data labels and/or supporting documents are not in English.

Prematurely discontinued trials that have insufficient enrollment/exposure to warrant analysis may not be listed.

Data access or data provision may be restricted for the data that are technically difficult to provide or have practical limitations.

Interim data from completed or ongoing clinical trials will generally not be shared.

Information provision may be limited for studies that are ongoing or planned for regulatory review by competent regulatory authorities.

Dataset provided: CDISC/SDTM、ADaM

Definition provided: define.xlm

Protocols with any amendments. This describes the objectives, design, methodology, statistical considerations, and organization of a clinical trial and information about all amendments.

Annotated case report form. This is a blank case report form with descriptions of the data collected and how they are described in the dataset.

Reporting and analysis plan. This describes methods of analysis and procedures for data handling that Kyowa Kirin used for the study report.

Dataset specifications. This is the meta-data which describes the datasets e.g., variable labels, variable descriptions, code lists, formats.

Clinical study report. This is the report of efficacy and safety data from the study. It forms the basis of submissions to regulatory authorities such as the Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Appendices that contain no patient relevant data (e.g. audit certificates or manuals from providers of various diagnostic services) as well as individual patient level data (e.g. narratives) are not included. Documents will be redacted to protect personal data of study participants, study personnel, and Kyowa Kirin employees, and to protect Kyowa Kirin’s commercially confidential information, including intellectual property rights.

• The primary manuscript of the study has been published or accepted for publication.
• Whether Kyowa Kirin is able to provide the requested data. For example, some non-interventional (or observational) studies use data from third party databases under license agreements which prevent Kyowa Kirin from providing access to the data. Researchers may seek access to data directly from these third party databases under similar agreements.
• Whether Kyowa Kirin has the legal authority to provide the data. For example, Kyowa Kirin may not have the legal authority because the medicine has been out-licensed to another company.
• If agreement to disclosure of clinical data is not gained with a co-development/research/marketing/promotion partner for a compound/product.
• Whether Kyowa Kirin considers it feasible to anonymise the data without compromising the privacy and confidentiality of research participants. For example, anonymisation of data from studies of rare diseases is more difficult to achieve and will be reviewed on a case-by-case basis.
• If there are considerable operational constraints (costs, resource) to providing access to the data.